A multitude of minimally invasive surgical techniques have recently arisen, including such procedures as laparoscopic cholecystectomy and laparoscopic nephrectomy which present significant advances in clinical surgery. Until recently the laparoscopic approach has been limited either to a diagnostic function or to the removal of small amounts of tissue or to thin wall, hollow organs such as the gall bladder and appendix. For example, in laparoscopic cholecystectomy, a miniature TV camera and surgical instruments are inserted through keyhole size punctures in the abdomen. A camera displays the patient's internal organs on a monitor which the surgeon watches while manipulating the surgical tools to dissect and isolate the gall bladder within the abdominal cavity. The possibilities of video surgery or telescopic surgery are not limited to gall bladders since medical procedures have applied such technology to surgical treatment of ulcers, hernias and appendectomies.
Surgical disciplines dealing with minimally invasive surgery addressing intra-abdominal surgery have been impacted by the laparoscope. Laparoscopic procedures for gynecology, for which the laparoscope was originally designed, include removal of small uterine myomata, tubal ligation, and ovariectomy. In general surgery, cholecystectomy, the diagnosis of the acute abdomen, herniorrhaphy, and appendectomy all can be done laparoscopically. In urology, the diagnosis of the cryptochide testicle and more recently pelvic node dissection have been accomplished using a laparoscopic approach.
Laparoscopic cholecystectomy, like open incisional surgery, removes the gall bladder in order to cure gall bladder disease such as gall stones, i.e. pebble size globs of cholesterol that accumulate in the organ and cause painful attacks when they clog certain digestive passageways. Patients who undergo laparoscopic surgery not only endure less pain and scarring, also experience substantially reduced hospital bed recovery time and return to active lives much sooner than patients experiencing open cavity surgery.
Attempts to remove larger solid organs such as kidneys, spleen, liver and uterus, have been frustrated by the lack of a rapid tissue morsellator apparatus, suitable entrapment envelope and methods for manipulating the envelope for receiving and retaining the vigorous morsellation breakup and evacuation of the organ tissue. Unlike the malleable gall bladder, which lies accessible on the liver, the kidney, for example, is solid, and embedded, and in fact entangled in blood vessels. Even with improved morsellators, there are increased risks due to the large solid organs requiring substantially more energy to particularize and evacuate. Possible spillage of infected organ contents or contamination from such organ tissue have stalled the development of laparoscopic approaches principally due to the difficulties of isolating and bagging the removed organ in an entrapment envelope. The strength and quality of the entrapment envelope and its maneuverability remains paramount in the full development of laparoscopic techniques in order to provide sufficient safety expectation which precludes tissue contamination or bacterial spillage into the cavity.
Removal of large solid organs such as kidney laparoscopically, despite recent developments and advances in apparatus, continues to need improvements in tissue dissection, improvements in the method and apparatus for organ entrapment, as well as a means for effective fragmentation and evacuation of the entrapped organ. Laparoscopic equipment for tissue dissection has been the subject of considerable developmental improvement, for example the availability of irrigation/aspiration devices, delicate curved and straight forceps, and an effective multiload clip applier now enables the surgeon to dissect and secure a variety of vascular structures, including the renal vessels. Despite these advancements, two interrelated problems still exist before a large solid organ such as the kidney can be removed in an efficient and safe manner includes organ morsellation and organ entrapment.
Researchers have utilized farm pigs in their various laparoscopic surgical procedures in order to further advance equipment and procedures. A keyhole incision was made in the animal in the midline of the abdomen with insertion of a telescope filled with a miniature TV camera and associated surgical instruments into the abdominal cavity. After appropriate isolation, dissection and clamping of the multiple arteries and veins, the kidney was elevated from its retroperitoneal bed and dissected therefrom, thus being available in the abdominal cavity as a separated, free form organ. A plastic or nylon sack was then introduced into the abdominal cavity using forceps and the like in order to open the mouth of the sack for purposes of inserting into the sack the severed kidney. Various difficulties have arisen in trying to insert and manipulate, i.e. open the sack and previously have required other keyhole entry for special apparatus to perfect the opening and the transfer of the severed kidney into the sack. In some procedures a drawstring on the sack was gathered using forceps in order to close the sack, which is then partially pulled into a sheath. The sheath and related apparatus is then removed from the abdomen, leaving the neck of the sack to be manually grasped upon exit of the skin of the abdomen. With the kidney suspended in the sack and drawn up to the underside of the abdominal wall, the mouth of the sack is reopened in order to attempt to morsellate the kidney in the sack and thereby extract the entire organ in particulate form from the sack and eventually the sack itself. Attempts to morsellate the kidney electrically with an orthopedic drill or available morsellation devices have not been satisfactory. A Cavitron ultrasonic aspirator was used to fragment and aspirate kidneys from a sack, albeit in a very slow procedure. Morsellation devices have been used which can expedite the fragmentation of the organ. However, such morsellation devices present problems regarding the plastic bag, i.e. damage of the bag from the morsellation device, thus spillage and contamination of the abdominal cavity.
Organ entrapment and organ morsellation, especially the large solid organs such as kidneys, spleen, liver and the like, continue to be a concern to the surgeon because of the safety factor as well as surgical procedure complexities and surgical time span. Although manual laparoscopic morsellators are available which are designed predominantly for use with small tissue items, such apparati are not readily suitable for large solid organ morsellation. Other types of electrical or ultrasonic morsellators such as orthopedic drills or ultrasonic surgical aspirators, rely on active suction to help evacuate the fragmented tissue. Such suction has been found to rapidly deplete the CO.sub.2 pressurized peritoneum cavity resulting in collapse of the abdominal cavity and loss of visibility.
A recently issued United States patent, U.S. Pat. No. 5,037,379 issued Aug. 6, 1991 entitled Surgical Tissue Bag and Method for Precutaneously Debulking Tissue, provides yet another attempt to overcome some of the procedural and apparatus shortcomings existing in laparoscope organ retrieval technology. The '379 Patent teaches a tissue bag comprised of two layers of materials, an inner layer of a puncture-resistant material and an outer layer of moisture-proof material for containing cells and fluid. The bag material is foldable and flexible for insertion through an access opening into the surgical site. A draw-string is attached to the open end of the bag to close the bag when the tissue is contained therein and pulled through the puncture site in the outer surface of the skin. The bag is bulky in the way it is formed, the two layers comprising a single sheet having opposite first and second ends folded back to contact each end to form a folded side of the bag. The rather stiff fold-back portions along one side and across the bottom as illustrated in FIG. 1A is touted as advantageously causing the open end of the bag to open for receiving tissue once inserted into the body cavity. Such a bulky bag mechanism appears to be cumbersome and awkward in the sense of manipulating the bulk through the keyhole incision as well as manipulation within the body cavity.
In view of these continuing procedural and apparatus shortcomings, the present invention presents an improved laparoscopic organ retrieval apparatus and procedures for entrapping the organ in an impermeable entrapment envelope and means for readily deploying said envelope into the abdominal cavity as well as manipulating the opening of the envelope and the closing of same upon the insertion of the organ. Such means for manipulating the entrapment envelope immediately isolate the diseased tissue from the abdominal contents. In addition, the entrapment envelope is constructed of sufficiently impermeable materials to allow the use of electrical morsellator devices relying on partial suction evacuation and substantial cutter head adaptations which allow for the relatively quick fragmentation and evacuation of the organ. The entrapment envelope must be of a thin, low-bulk material and yet have sufficient strength to withstand high speed motor driven morsellation of solid tissue without perforation of the envelope, thereby precluding seeding of the abdomen with diseased fragments or bacteria from the morsellated tissue.